• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AESPIRE 7900 ANESTHESIA GAS MACHINE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DATEX-OHMEDA, INC. AESPIRE 7900 ANESTHESIA GAS MACHINE Back to Search Results
Model Number 1009-9012-000
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/30/2018
Event Type  Malfunction  
Manufacturer Narrative

The customer site advised that the patient information from this event can't be determined. A ge healthcare service representative performed a checkout of the equipment and confirmed the reported complaint. The bag/vent switch was replaced, and the unit was returned to service.

 
Event Description

The hospital reported an intermittent failure of the unit to switch to mechanical ventilation when requested. There is no report of patient injury.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameAESPIRE 7900
Type of DeviceANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI
Manufacturer Contact
joseph seliga
3000 n grandview blvd.
waukesha, WI 
MDR Report Key7647716
MDR Text Key112710104
Report Number2112667-2018-01293
Device Sequence Number1
Product Code BSZ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK050626
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial
Report Date 06/28/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/28/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number1009-9012-000
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/30/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/09/2006
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-